🏛️ Verified NIH Record • Updated 2025-08-05
Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study (NCT05136820)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Occlutech International AB
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this clinical study is to assess the safety and effectiveness of the Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) while on stable guideline directed medical therapy (GDMT) as outlined in the Guidelines for the Management of Heart Failure.
Who can join: Review the eligibility criteria below.
Location: Arizona Heart Rhythm Center — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Arizona Heart Rhythm Center — Phoenix, Arizona
- North Shore Northwell University Hospital Lenox Hill — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Failure With Preserved Ejection Fraction (HFpEF)
- A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF — Fairhope, Alabama
- Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) — Chicago, Illinois
- ELEVATE-HFpEF Clinical Study — Phoenix, Arizona
- Hearts on Fire: Targeting Inflammation in Heart Failure With Preserved Ejection Fraction — Gainesville, Florida
Explore by condition: All Heart Failure With Preserved Ejection Fraction (HFpEF) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.